BEUDAMED
    600 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    Scaffold, Dissection Repair

    FDA Pre-Market Approval
    FDA Class 3 ·Tack Endovascular System (4F, 1.5-4.5mm)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent System

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·Esteem® Totally Implantable Hearing System

    Shockwave Intravascular Lithotripsy System

    FDA Pre-Market Approval
    FDA Class 3 ·Shockwave C2 Intravascular Lithotripsy (IVL) Catheter, VL Generator and Connector Cable Kit, IVL Connector Cable (Replac

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INGEVITY+ Active Fixation Pace/Sense Lead

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2000/2100 1.5 AND 3T

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Neuroform Atlas® Stent System

    Stent, Renal

    FDA Pre-Market Approval
    FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·NIT-OCCLUD PDA

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·MT PAS ACUITY X4

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·NaviStar THERMOCOOL Deflectable Diagnostic/Ablation Catheter

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Ranger™ Paclitaxel-Coated PTA Balloon Catheter

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 28-8 pharmDx